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In the dose expansion (\n                    <jats:italic>n<\/jats:italic>\n                    \u2009=\u200968), patients with\n                    <jats:italic>MDM2<\/jats:italic>\n                    -amplified (well-differentiated and de-differentiated liposarcomas [WDLPS and DDLPS], glioblastoma multiforme [GBM], or other solid tumors [OST]), MDM2-overexpressing ER+ breast cancer (BC), or MM received AMG 232 at the maximum tolerated dose (MTD). Safety, pharmacokinetics, pharmacodynamics, and efficacy were assessed.\n                    <jats:italic>Results<\/jats:italic>\n                    AMG 232 had acceptable safety up to up to 240\u00a0mg. Three patients had dose-limiting toxicities of thrombocytopenia (\n                    <jats:italic>n<\/jats:italic>\n                    \u2009=\u20092) and neutropenia (\n                    <jats:italic>n<\/jats:italic>\n                    \u2009=\u20091). Due to these and other delayed cytopenias, AMG 232 240\u00a0mg Q3W was determined as the highest tolerable dose assessed in the dose expansion. Adverse events were typically mild\/moderate and included diarrhea, nausea, vomiting, fatigue, decreased appetite, and anemia. AMG 232 plasma concentrations increased dose proportionally. Increases in serum macrophage inhibitor cytokine-1 from baseline were generally dose dependent, indicating p53 pathway activation. Per local review, there were no responses. Stable disease (durability in months) was observed in patients with WDLPS (3.9), OST (3.3), DDLPS (2.0), GBM (1.8), and BC (1.4\u20132.0).\n                    <jats:italic>Conclusions<\/jats:italic>\n                    In patients with P53WT advanced solid tumors or MM, AMG 232 showed acceptable safety and dose-proportional pharmacokinetics, and stable disease was observed.\n                  <\/jats:p>","DOI":"10.1007\/s10637-019-00840-1","type":"journal-article","created":{"date-parts":[[2019,7,29]],"date-time":"2019-07-29T18:02:22Z","timestamp":1564423342000},"page":"831-843","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":121,"title":["Phase 1 study of the MDM2 inhibitor AMG 232 in patients with advanced P53 wild-type solid tumors or multiple myeloma"],"prefix":"10.1007","volume":"38","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4901-6519","authenticated-orcid":false,"given":"W. 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Gounder declares personal fees and advisory board for Bayer, Epizyme, Karyopharm, Amgen Inc., Daichi, Springworks, Tracon, and GlaxoSmithKline. Jean Yves Blay declares research support and honoraria from Amgen Inc., Roche, and Novartis. Philippe A. Cassier declares research support from Novartis, Astra-Zeneca, Plexxikon, Merck Sharp & Dohme, and Debio; institutional research support from Abbvie, Bayer, Bristol-Myers Squibb, GlaxoSmithKline, Merck Sharp & Dohme, Novartis, Roche, Lilly, and Taiho; honoraria from Amgen Inc., Novartis, and AstraZeneca; and travel from Bristol-Myers Squibb, Roche, and Amgen Inc. Jean-Charles Soria declares employment by MedImmune. Sant Chawla declares honoraria, consultant\/advisor, research funding, and speakers\u2019 bureau for Amgen Inc., Roche, Threshold Pharmaceuticals, GlaxoSmithKline, CytRx Corporation, Ignyta, Immune Design, TRACON Pharma, SARC, Karyopharm Therapeutics, and Janssen. Andrew J. Wagner declares research support from Amgen Inc.; personal fees from Eli Lilly, Loxo, and Five Prime Therapeutics; and grants from Merck, Sanofi, Daichi-Sankyo, Plexxikon, Karyopharm, Five Prime Therapeutics, and AADI. David Siegel declares a grant from Celgene; speakers bureau and advisory boards for Amgen Inc., Celgene, Bristol Myers-Squibb, Janssen, Takeda, and Karyopharm; and advisory board for Merck. Haby A. Henary and Erik Rasmussen declare employment and stock ownership in Amgen Inc. Larry Gluck, Richard Frank, Ferry Eskens, Vincent de Weger, and Filip De Vos have no conflicts to disclose.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and\/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical approval"}},{"value":"Informed consent was obtained from all individual participants included in the study.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Informed consent"}},{"value":"Amgen Inc.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Financial support"}}]}}